St Helens and Knowsley Teaching Hospitals NHS Trust, Merseyside, UK.
NIHR HPRU in Gastrointestinal Infections at University of Liverpool, Liverpool, UK.
BMC Med. 2021 Jun 29;19(1):147. doi: 10.1186/s12916-021-02017-1.
Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK.
A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices.
There were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86-1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68-1.19).
Rotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.
轮状病毒感染已被提出是乳糜泻（CD）和 1 型糖尿病（T1D）的危险因素。英国于 2013 年引入了婴儿轮状病毒疫苗接种。我们之前已经表明，轮状病毒疫苗接种对综合征（如住院癫痫发作）可能具有有益的非靶向作用。因此，我们调查了轮状病毒疫苗接种是否可以预防英国的 CD 和 T1D。
使用来自临床实践研究数据链接的初级保健记录，对 2010 年至 2015 年之间出生的儿童进行了队列研究。从 6 个月到 7 岁对儿童进行随访，对结局、死亡或离开实践进行了删失。CD 被定义为 CD 的诊断或无麸质食品的处方。T1D 被定义为 T1D 的诊断。暴露是轮状病毒疫苗接种，定义为一剂或多剂。使用混合效应 Cox 回归来估计风险比（HR）和 95%置信区间（CI）。模型针对潜在的混杂因素进行了调整，并包括一般实践的随机截距。
队列中有 880629 名儿童（48.8%为女性）。共有 343113 名（39.0%）参与者接受了轮状病毒疫苗接种；在轮状病毒疫苗接种推出后出生的参与者中，93.4%接受了疫苗接种。研究参与者提供了 4388355 人年的随访，中位随访时间为 5.66 人年。有 1657 例 CD 病例，发病率为每 100000 人年 38.0 例。与未接种疫苗的儿童相比，接种疫苗的儿童的 CD 调整后 HR 为 1.05（95%CI 0.86-1.28）。女性的危险比男性高 40%。有 733 名参与者记录了 T1D，发病率为每 100000 人年 17.1 例。在调整分析中，轮状病毒疫苗接种与 T1D 的风险无关（HR=0.89，95%CI 0.68-1.19）。
自 2006 年获得许可以来，轮状病毒疫苗接种已大大降低了腹泻病的发病率和死亡率。我们从这项大型队列研究中得出的发现并没有提供证据表明轮状病毒疫苗接种可以预防 CD 或 T1D，也没有与增加的风险相关，这进一步证明了轮状病毒疫苗的安全性。
